Kornimate/medical-research-clean huggingface dataset:
comparison study of mdx-010 (ctla-4) alone and combined with docetaxel in the treatment of patients with hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: the primary objectives of the study are to determine the safety and activity of multiple doses of mdx-010 in patients with hormone-refractory prostate cancer (hrpc), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with mdx-010


Eligibility criteria:
inclusion criteria: * clinical diagnosis of adenocarcinoma of the prostate. * metastatic prostate cancer (positive bone scan or measurable disease). * progressive disease after androgen deprivation. * no prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer). exclusion criteria: * other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years. * previous occurrence of autoimmune disease. * active infection requiring therapy including hiv or chronic hepatitis.
assessing her2/neu expression in gastric cancer with dual or multiple tumor tissue paraffin blocks

Conditions: Gastric Cancer; HER-2

Summary: one paraffin block is routinely used for human epidermal growth factor receptor 2 (her2/neu) immunohistochemistry (ihc) assessment. here, investigators investigated if picking two or multiple paraffin blocks for her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of her2/neu ihc assessment due to intratumoral heterogeneity.


Eligibility criteria:
inclusion criteria: age between 18 to 80; received curative surgery with primary gastric adenocarcinoma; did not receive any preoperative treatment. exclusion criteria: none.

Keywords: gastric cancer her2/neu dual paraffin blocks trastuzumab
treatment of adipose tissue and skin laxity at the buttocks by pdlla, us and rf

Conditions: Local Fat Deposits

Summary: local body fat and lax skin is treated with a combined approach of pdlla injections and topical ultrasound and radiofrequency.


Eligibility criteria:
inclusion criteria: * adults over 18 years * patients eligible to be treated with radiofrequency and ultrasound * all genders exclusion criteria: * patients displaying contraindications for treatment with radiofrequency and ultrasound * pregnancy * immune diseases * active virus infections
immunodeficiency and cancer: identification of congenital immune system defects underlying paediatric lymphomas

Conditions: Immune Deficiency

Summary: inborn errors of immunity (iei) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of iei, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. lymphomas, especially non-hodgkin's lymphomas (nhl) are frequently associated with congenital defects of the immune system, in particular diffuse large b-cell lymphoma and burkitt's lymphoma. preliminary analyses conducted on 6 patients diagnosed with nhl allowed the identification of genetic variants in genes associated with iei. in clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. the identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. the study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas.


Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of hodgkin's lymphoma (hl) or non-hodgkin's lymphoma (neil) with or without signs of immune dysregulation (lymphoproliferation, autoimmunity, hypogammaglobulinaemia, family history of immunodeficiency). * patients with previous hl or neil lymphoma who have developed, concomitantly with the tumour or subsequently, clinical manifestations mentioned above attributable to a congenital defect of immunity. exclusion criteria: * patients with known genetic diseases, or who do not consent to participate in the study
establishment of a sensitive system for analysis of child-bearing women vaginal microbiota

Conditions: Vaginitis

Summary: the vaginal microbiota is an important biological barrier for host against pathogens or opportunistic pathogens. undermining the balance of the vagina is closely related to infectious diseases and tumors. the vaginal microbiota of child-bearing women of age is dominated by lactobacillus species, including major four species: lactobacillus crispatus, lactobacillus jensenii, lactobacillus gasseri and lactobacillus iners, followed by obligate anaerobes such as gardnerella vaginalis, atopobium vaginae, mobiluncus curtisii, and prevotella . currently, there are almost 99% bacteria can not to be found with bacterial culture. based on microscopy and conventional culture method to obtain vaginal microflora information have a variety of deviation. for this reason, the in-depth study of complex vaginal flora and the correct understanding of disease faces a serious obstacle. with the development of high-throughput sequencing technology， metagenomics can get all the composition and distribution of microorganisms from the sample which traditional knowledge may not be with microorganism culture method. therefore, re-evaluation of existing microflora diagnostic criteria for clinical diagnosis of the disease is necessary. in this study, the investigators use high-throughput sequencing technology to detect women of childbearing age vaginal microflora of metagenomic distribution. including bacteria, fungi, viruses, protozoa, and other microorganisms. based on the study results of metagenomic, the investigators want to re-cognition the"normal flora"of women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.


Eligibility criteria:
inclusion criteria: * normal child-bearing women exclusion criteria: * pregnancy women * lactating women * using antibiotics or vaginal topical application of antibiotics over a month * have sexual activity in 3 days

Keywords: metagenomics vaginal microflora high-throughput sequencing
nurse-led sheath insertion in cardiac patients

Conditions: Coronary Artery Disease

Summary: the aim of project nushi is to elucidate, that radial sheath insertion can be performed by nurses and physicians with the same level of comfort and safety.

background: insertion of sheath in the radial artery in connection with examination and treatment of patients with coronary artery disease is usually performed by specialized invasive cardiologists or trainees. whether sheath insertion can be performed by nurses with the same level of comfort and pain is uncertain. eligibility: patients referred for coronary angiography (cag) and/or percutaneous coronary intervention (pci) due to suspicion of coronary artery disease are included randomization: patients are randomized 1:1 to sheath insertion by nurse or physician methods: insertion of 5 or 6 radial sheaths is performed in local anesthesia outcome measures: comfort and pain level is registered from immediately after sheath insertion until start of cag/pci. additional outcome measures: oximetry test is performed immediately after sheath removal - and repeated after 1 month in case of occlusion. any complication is recorded from the patient enters the wake-up room until discharge. all patients are contacted after 1 year in order to register adverse events.

Eligibility criteria:
inclusion criteria: * patients suspected of having coronary artery disease * with normal puls oxymetry on the right hand * understands patient information and accepts to participate exclusion criteria: * under consideration for cardiac valve replacement * systolic blood pressure persistently \>180 mmhg
radiance continued access protocol

Conditions: Hypertension; Hypertension, Resistant to Conventional Therapy; Vascular Diseases; Cardiovascular Diseases

Summary: radiance cap is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the paradise system, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.


Eligibility criteria:
inclusion criteria: * average office bp ≥140/90 mmhg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent * documented daytime abp ≥135/85 mmhg following 4 week run-in/standardization period on antihypertensive medication regimen exclusion criteria: * renal artery anatomy ineligible for treatment * secondary hypertension not including sleep apnea * type i diabetes mellitus or uncontrolled type ii diabetes (defined as plasma hba1c ≥9.0%) * egfr \<40 * brachial circumference ≥42 cm * any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent * documented repeat (\>1) hospitalization for hypertensive crisis within 3 months prior to consent * documented confirmed episode(s) of unstable angina within 3 months prior to consent * chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea * primary pulmonary hypertension * night shift workers * pregnant, nursing or planning to become pregnant

Keywords: blood pressure uncontrolled hypertension essential hypertension resistant hypertension denervation
pressure ulcer healing with microcyn

Conditions: Pressure Ulcer; Spinal Cord Injuries

Summary: the purpose of this study is to test how well microcyn™ works on stage 3 and stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.


Eligibility criteria:
inclusion criteria: * age \> 17 years * persons with spinal cord injury * having stage iii/iv pressure ulcer(s) * able to fulfill all obligations of the study exclusion criteria: * pressure ulcers scheduled for surgical closure within 14 days * use of any immunosuppressant medications within 30 days of screening * having conditions that put the subject at significant risk * medically unstable or has a life expectancy of less than 12 months * current enrollment in an investigational drug or device study or participation in such a study within the last 30 days * pregnant women

Keywords: spinal cord injuries pressure ulcer
effect of ketamine on analgesia post-cardiac surgery

Conditions: Pain, Postoperative

Summary: randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.

this is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative ketamine administration on pain after coronary artery bypass surgery. patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. opioid dose administered in the first 48 hours will then be documented as the primary outcome

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery exclusion criteria: * minimally invasive cardiac surgery * preoperative opioid use * preoperative hepatic or renal dysfunction

Keywords: ketamine cardiac surgery pain
pilot study of navigational bronchoscopy and transthoracic needle biopsy

Conditions: Peripheral Pulmonary Nodules

Summary: the goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (ppn).

accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (tbbx), and/or do not lie within an accessible airway. in this study, investigators hope to evaluate new technologies to aid in ppn biopsy using navigation bronchoscopy (nb) combined with navigation transthoracic needle aspiration (n-ttna) sampling of a ppn. patients meeting inclusion criteria who consent will undergo a convex endobronchial ultrasound (ebus) bronchoscopy for evaluation and sampling of the mediastinum and hilum. following this, nb will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with r-ebus and fluoroscopy. if the lesion is localized by nb and/or radial ebus in conjunction with nb, tbbx will be taken. at the conclusion of tbbx sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. if the lesion was not able to be localized via nb and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo n-ttna at the same ppn during the same procedure time. it is envisioned that between 8-12 patients will require a n-ttna to complete diagnosis.

Eligibility criteria:
inclusion criteria: * target patient population: patients with a peripheral pulmonary nodule as identified on ct chest ≤3cm from the pleura will be recruited. a ppn will be defined as a lesion \>10mm and \<3cm in diameter surrounded by lung parenchyma on ct chest. the decision for biopsy of the ppn will be made by the treating physician and agreed upon by the patient. * participants must be at least 18 years old or older * no bleeding disorders * provide informed consent. exclusion criteria * less than 18 years * lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure * inability to give informed consent

Keywords: lung nodule biopsy
mbc physical activity study

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma

Summary: this clinical trial evaluates the impact of a tailored physical activity program on physical activity in patients with breast cancer that has spread from where it first started to other places in the body (metastatic). it has been shown that decreased physical activity contributes to poor performance and quality of life. evidence has also shown that exercise could improve physical fitness, physical functioning, quality of life, and cancer-related fatigue, however, there is concern that it may not be available to those with physical limitations. the proposed physical activity program offers a comprehensive and individualized assessment for each metastatic breast cancer patient and includes a high quality, tailored exercise home-based program designed by an advanced qualified cancer exercise specialist. a tailored physical activity program may improve physical activity in metastatic breast cancer patients.


Eligibility criteria:
inclusion criteria: * female * aged 18 and older * able to read and speak english * diagnosed with metastatic breast cancer within 60 months of study enrollment * performance status eastern cooperative oncology group (ecog) 0-2 * insufficiently inactive defined as answer "no" to screening question "on average, do you engage in at least 75 minutes a week of vigorous activity (like jogging) or at least 150 minutes a week of moderate activity (like a brisk walk)?" * able to comprehend and sign a written informed consent (no cognitive decline) * willing to comply with all study procedures and be available for the duration of the study through at least week 2 of 2unstoppable * medically cleared by co-investigator or principal investigator (pi) to engage in aerobic and resistance exercise intervention * access to a smart device and have an active wi-fi connection at home exclusion criteria: * severe or unstable cardiopulmonary, metabolic, or renal disease * unable to walk safely without physical assistance of another person or assistive device * any condition that may limit the ability to comply with behavioral and physical recommendations of the virtual exercise program * pregnancy
evaluation of immunological disorders of t lymphocytes and endocrinological disorders as pathogen factors in patients with metaplasia of urinary bladder

Conditions: The Follow-up Duration Was 1-8 Years.; The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,; Urinary Urgencies, Pollakiuria, Difficulty in Initiating Micturition, Pain in Hypogastrium,; Night Wetting and Day Wetting, Menstruation's Disorders, Urolithiasis, Defects of Urinary; System and Hematuria.

Summary: background: squamous metaplasia refers to the pathological transformation of the urothelium leading to non-keratinised stratified squamous metaplasia (n-ksm). objective: to present the investigators experiences in the diagnosis and treatment of n-ksm of the urinary bladder in children.

design, setting, and participants: in this study, the investigators present their experiences in the diagnosis and treatment of n-ksm of the urinary bladder in children aged from 5 to 17 years. from 2005 to 2013, metaplasia was diagnosed in 119 patients - 116 girls and 3 boys. the reasons behind visiting the hospital were non-specific intense pain in the abdomen, recurrent urinary tract infections, and urination disorders. the most common symptoms of urinary bladder dysfunction were pollakiuria and difficulties in initiating micturition and retention of urine (reduced detrusor muscle activity). outcome measurements and statistical analysis: in 20 patients (16.8%), metaplasia was incidentally diagnosed during cystoscopy performed for other causes. only the children whose bladders showed metaplastic changes on cystoscopy were subjected to a bladder biopsy for collecting specimens for further histopathological examination.

Eligibility criteria:
inclusion criteria: * the follow-up duration was 1-8 years. * the main reasons behind visiting the hospital were: 1. recurrent urinary tract infection, 2. urinary urgencies, 3. pollakiuria, 4. difficulty in initiating micturition, 5. pain in hypogastrium, 6. night wetting and day wetting, 7. menstruation's disorders, 8. urolithiasis, 9. defects of urinary system and hematuria. exclusion criteria: * no confirmation of squamous metaplasia of the urinary bladder in diagnostic cystoscopy

Keywords: metaplasia, dysfunction, urinary bladder, children
trial of auto continuous positive airway pressure (cpap)

Conditions: Obstructive Sleep Apnea

Summary: background: in patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autocpap) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. once breathing becomes normal, pressure slowly declines. autocpap devices have never been tested in phase i studies. the investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.

material and methods: we will submit one normal (confirmed with two polysomnographies, psg) subject to a double blind study. pairs of psg will be performed on successive days once a week, one night with a 4 cm water fixed pressure cpap device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autocpap devices programmed to work between 4 and 15 cm h2o pressure. the same mask and headgear will be used throughout the study. the subject and the physicians reading the tracings will ignore which device is being used on which night.

Eligibility criteria:
inclusion criteria: * normal subject * male and female * age 18 to 65 years old exclusion criteria: * obstructive sleep apnea * unable to sleep with a cpap device

Keywords: treatment cpap sleep apnea
music and feeding in nicu

Conditions: Feeding; NICU; Preterm Infants; Mozart; Weight Gain

Summary: the purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the nicu.


Eligibility criteria:
inclusion criteria: * • neonates between the gestational ages of 28 weeks and 32 weeks and 6 days * parents ≥18 years of age * english speaking parents * breastmilk as intended primary form of nutrition exclusion criteria: * congenital anomalies affecting hearing or feeding skills * patients requiring hfov or hfjv